BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERSHEATH

    MDR report key: 6165429 · Received December 11, 2016

    Report

    Report Number
    9612126-2016-00004
    Event Type
    Malfunction
    Date Received
    December 11, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 15, 2015
    Manufacturer
    TOGO MEDIKIT CO. LTD.
    Product Code
    DRE
    PMA / PMN Number
    K141070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE COMPLAINT PRODUCT, ONLY THE SHEATH WAS RETURNED. BY VISUAL INSPECTION OF APPEARANCE, IT WAS CONFIRMED THAT THE SHEATH CAME OFF FROM SHEATH MAIN BODY. THE MARK WHICH IS MADE BY PRESS FITTING OF FIXTURE ON THE PROXIMAL END OF SHEATH WAS LOCATED. ADDITIONALLY, IT WAS FOUND THAT THE PORTION LOCATED BETWEEN 170 MM AND 195 MM FROM PROXIMAL END OF SHEATH WAS STRETCHED/ELONGATED. THE INNER AND OUTER DIAMETER OF THE SHEATH IN THE AREA THAT WAS NOT ELONGATED WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. SHEATH MAIN BODY WAS CUT AND IT WAS CONFIRMED THAT THERE WAS A FIXTURE INSIDE THE SHEATH MAIN BODY. THE FIXTURE WAS THEN REMOVED FROM THE SHEATH MAIN BODY AND THE SURFACE WAS EXAMINED THERE WAS NO ABNORMALITY OBSERVED ON SURFACE FINISHING (CRUDE PROCESSING). ANOTHER SHEATH AND SHEATH MAIN BODY WHICH ARE SAME TYPE WERE CONNECTED WITH THE FIXTURE TAKEN OUT FROM RETURNED PRODUCT. THE JOINT STRENGTH WAS MEASURED AND THE RESULT WAS WITHIN THE SPECIFICATION. SINCE NO ABNORMALITIES WERE FOUND DURING EXAMINATION OF THE SAMPLE, ALTHOUGH ELONGATION OF THE SHEATH WAS OBSERVED, IT IS THAT POSSIBLE THAT THE SHEATH CAME OFF FROM SHEATH MAIN BODY BY APPLICATION OF UNACCEPTABLE LEVEL OF TENSILE STRENGTH TO THE SHEATH. THE MEDICAL DEVICE INVOLVED IN THE REPORTED EVENT IS SOLD ONLY IN (B)(6). THEREFORE, THE INFORMATION ON THE EQUIVALENT DEVICE TO THE COMPLAINT DEVICE THAT WAS CLEARED UNDER K141070.

    Description of Event or Problem · 1

    ON (B)(6) 2015 AT THE (B)(6) HOSPITAL, IT WAS REPORTED THAT DURING USE OF THE SUPERSHEATH DEVICE FROM LOT NUMBER 15H18CK, THE SHEATH TUBE SEPARATED FROM THE SHEATH BASE. THERE WAS NO REPORTED PATIENT IMPACT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816031 SUPERSHEATH DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE TOGO MEDIKIT CO. LTD. 15H18CK

    Patients

    Seq Age Sex Outcome Treatment
    1